Actively Recruiting
Workflow Study of the VARIPULSE Catheter With the TRUPULSE Generator for Treatment of Persistent Atrial Fibrillation Using VARIPULSE Pro Software
Led by Biosense Webster, Inc. · Updated on 2026-06-05
50
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical workflow of a pulsed field ablation system using the VARIPULSE catheter, TRUPULSE generator, and new VARIPULSE Pro software for treating participants with persistent atrial fibrillation (PsAF), a condition characterized by irregular, rapid heart rhythm lasting over 7 days without stopping on its own. The study aims to better understand the use of this device system in managing symptomatic PsAF. Participants will undergo cardiac ablation using pulsed field ablation with the VARIPULSE catheter and TRUPULSE generator equipped with VARIPULSE Pro software. This treatment focuses on pulmonary vein isolation to manage PsAF symptoms. The study involves one treatment group receiving this investigational device combination. During the study, participants will have several intraoperative measurements such as total procedure time, pulsed field application time, number of applications, and fluoroscopy time. Researchers will monitor acute effectiveness and safety outcomes including serious and non-serious adverse events up to three months post-procedure. The study collects data on pulmonary vein isolation durability and requires participants to comply with all pre-, post-, and follow-up testing and requirements. Total participation duration depends on follow-up schedules extending up to 90 days after the ablation.
CONDITIONS
Brief Title
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with symptomatic persistent atrial fibrillation (PsAF)
- Selected to undergo an ablation procedure for management of arrhythmia by pulmonary vein isolation (PVI)
- Failed at least one antiarrhythmic drug (class I to IV) due to recurrent symptoms or intolerance
- Aged between 18 and 75 years
- Willing and able to provide consent
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
You will not qualify if you...
- Continuous atrial fibrillation lasting more than 12 months (longstanding persistent AF)
- Previous surgical or catheter ablation for atrial fibrillation
- Cardiac surgery or percutaneous coronary intervention within the past 60 days
- Previous coronary artery bypass grafting combined with valvular or other cardiac surgery
- Carotid stenting or endarterectomy
- Presence of left atrium thrombus
- Severe left atrial enlargement (diameter over 50 mm)
- Severely reduced left ventricular ejection fraction (less than 40%)
- Significant pulmonary vein anomaly or prior pulmonary vein stenosis
- Pre-existing hemi diaphragmatic paralysis
- History of blood clotting or bleeding disorders or anticoagulation contraindications
- Myocardial infarction within past 60 days
- Thromboembolic events within past 6 months
- Rheumatic heart disease
- Uncontrolled heart failure or NYHA class III or IV
- Severe mitral regurgitation
- Anticipated major cardiac or other surgery within next 12 months
- Unstable angina within past 6 months
- Acute illness or active infection
- Atrial fibrillation secondary to reversible causes like electrolyte imbalance or thyroid disease
- Intracardiac thrombus, tumor, patches, prosthetic valves preventing catheter use
- Conditions precluding vascular access or catheter manipulation
- Significant pulmonary disease causing chronic symptoms
- Significant congenital anomalies or medical problems
- Women who are pregnant, lactating, or planning pregnancy
- Current enrollment in another investigational study
- Contraindications for study devices
- Vulnerable populations requiring special safeguards
- Life expectancy less than 12 months
- Contraindications for MRI or presence of metal fragments
- Unresolved neurological deficits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure
Participants undergo pulsed field ablation using the VARIPULSE Catheter with TRUPULSE Generator and VARIPULSE Pro software for treatment of symptomatic persistent atrial fibrillation.
1 procedure visit (in-person)
Duration - Up to 3 months
Participants are monitored for safety and effectiveness of the ablation procedure, including assessment of adverse events and pulmonary vein isolation durability.
Multiple visits up to 3 months post procedure
Trial Site Locations
Total: 10 locations
1
AZORG campus Aalst Moorselbaan
Aalst, Belgium, 9300
Not Yet Recruiting
2
A.Z. Sint Jan
Bruges, Belgium, 8000
Not Yet Recruiting
3
Aarhus University Hospital
Aarhus N, Denmark, 8200
Actively Recruiting
4
Hospices Civils de Lyon HCL
Bron, France, 69500
Not Yet Recruiting
5
Institut Medico chirurgical Montsouris
Paris, France, 75014
Not Yet Recruiting
6
University Hospital of the Ruhr-University of Bochum
Bad Oeynhausen, Germany, 32545
Not Yet Recruiting
7
Azienda Ospedaliera Universitaria 'Policlinico Tor Vergata'
Roma, Italy, 00133
Not Yet Recruiting
8
IRCCS Policlinico San Donato
San Donato Milanese, Italy, 20097
Not Yet Recruiting
9
Vilnius University Hospital Santaros Clinics
Vilnius, Lithuania, 08406
Actively Recruiting
10
Erasmus MC
Rotterdam, Netherlands, 3015
Not Yet Recruiting
Research Team
W
Wannes Vermander
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here